The SENTRY Clinical Study (SENTRY)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01975090 |
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Recruitment Status :
Completed
First Posted : November 3, 2013
Results First Posted : October 12, 2017
Last Update Posted : October 27, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Embolism Deep Vein Thrombosis | Device: SENTRY IVC Filter | Not Applicable |
Pulmonary embolism (PE) is a prevalent disease with a significant morbidity and mortality. The estimated annual incidence is 1.45 per 1,000 patients, which translates to 1,350,000 cases per year in the United States. It is estimated that PE results in more than 200,000 deaths per year.
Currently there are two types of commercially available IVC filters utilized to prevent PE; permanent and retrievable. Both types of filters have documented limitations, such as tilting, migration, fracture, embolization and late deep vein thrombosis (DVT). Retrievable filters were developed to avert some of the late consequences of permanent filter, but in practice there is low success with eventual removal. In a series of 37 clinical studies, with a total of 6,834 patients the mean retrieval rate was 34%.
There are numerous design features of the SENTRY IVC Filter that are intended to improve on the limitations of available IVC filters and obviate the need for retrieval.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 129 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Prospective, Multi-Center Study of the Novate Sentry Bioconvertible Vena Cava Filter |
| Actual Study Start Date : | September 2014 |
| Actual Primary Completion Date : | August 2016 |
| Actual Study Completion Date : | December 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SENTRY IVC Filter
The SENTRY IVC Bioconvertible Filter
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Device: SENTRY IVC Filter
The SENTRY IVC Bioconvertible Filter is designed to provide temporary protection to subjects at transient, high risk of pulmonary embolism. Following conclusion of the protection period The SENTRY filter bioconverts, and filter arms withdraw towards the IVC wall for incorporation; obviating the need for retrieval. |
- Number of Subjects That Reported Clinical Success [ Time Frame: 6 Months ]
A Composite Endpoint including:
Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications
- Number of Participants With IVC Filter Related Complications [ Time Frame: 6months ]IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years of age
- fully informed subject who has executed an Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
- willing and able to comply with follow-up visit requirements
- requirement of transient PE protection of < 60 days
- documented or high risk of PE or DVT
- inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy
- IVC diameter compatible with filter diameter
- IVC length adequate for filter placement
Exclusion Criteria:
- intellectual impairment preventing understanding involvement in a clinical study
- hypersensitivity to device components
- impaired renal function defined as a serum creatinine level of > 2.0 mg/dL
- active systemic infection
- life expectancy < 12 months
- malignancy extending PE risk > 60 days
- pregnant or plans to become pregnant during study follow-up period
- participating in another investigational trial that has not reached its primary endpoint
- known hypercoaguable state
- inherited or acquired hemostatic disorder
- history or presence of a caval stent or filter
- inability to gain femoral or jugular access
- duplicated or left sided IVC
- renal vein thrombosis or IVC thrombosis extending to the renal veins
- jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery
- spinal irregularity that may interfere with successful device delivery
- occlusive or free-floating thrombus in the IVC
- contrast allergy that cannot be adequately pre-medicated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975090
Show 23 study locations
| Principal Investigator: | Michael D Dake, MD | Stanford University |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01975090 |
| Other Study ID Numbers: |
CI 036 |
| First Posted: | November 3, 2013 Key Record Dates |
| Results First Posted: | October 12, 2017 |
| Last Update Posted: | October 27, 2021 |
| Last Verified: | October 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
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Pulmonary Embolism Thrombosis Embolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |